Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
RayStation 7, UDI # 07350002010068 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RayStation 4.0 to RayStation 5 Service Pack 2 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
ENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
Olympus Corporation of the Americas
Class I - Dangerous
Products repaired with the incorrect service manual may be missing an O ring and are subject to rework with the corrected service manual.
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
Biocare Medical
Class I - Dangerous
Firm has identified product has no staining. If used, may result in invalid test results when used with controls in the clinical setting. Positive control would observe no staining. The clinical impact may result in the consumption of patient tissue sample and a delay in diagnosis.
Packaging of infant child reduced energy electrodes was not properly sealed.
IntelliSpace PACS 4.4, Product number 837507 - Product Usage: intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.
Philips Healthcare Informatics
Class I - Dangerous
Images may potentially become corrupt while using the system.
RayStation 6, UDI # 07350002010013 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Packaging of infant child reduced energy electrodes was not properly sealed.
RayStation 9B, UDI # 07350002010266 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
RayStation 8B Service Pack 1, UDI # 07350002010204 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities
Elekta Unity, Philips Marlin Software versions: R5.3.30, R5.3.31, R6.0.5331, R5.7.0, R5.7.1, R6.1.571
Elekta Limited
Class I - Dangerous
In TSM (Treatment Session Manager) Motion Monitoring workflows, under certain conditions there can be a mismatch between the contour data overlay with respect to the motion monitoring images of the monitored structure.
Class I - Dangerous
Distributed to the field without having completed design history files or design transfer activities